Generating and maintaining FDA-required documentation for software as a medical device can be tedious and time-consuming. We built a Claude Code skill to automate documentation for 510(k) submissions.

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Building software as a medical device (SaMD) requires extensive FDA documentation for 510(k) submissions, covering architecture, risk controls, and change history. This post demonstrates how to build a Claude Code skill—a specialized instruction set in a markdown file—to automate generation of Software Design Specifications (SDS). Using a Rails project as a testbed, the skill produced formatted documentation including versioning, risk classification, authentication flows, and diagrams. Integrating the Linear MCP server enabled automatic traceability links between code modules and issue tickets. However, AI-generated output had errors (e.g., hallucinating Devise when has_secure_password was used), so human review remains essential. The recommended approach is treating AI output as a strong first draft.

Claude Code skills: Automating FDA-required documentation for software as a medical device

Building a Claude Code skill for FDA documentation

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